The present invention relates to the decontamination arts. It finds particular application in conjunction with powdered reagents which are reacted in situ to form a liquid sterilant solution for sterilizing or disinfecting medical instruments and equipment and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable to a wide variety of technologies in which at least two components or reagents are kept separate until time of use and then combined through dissolution in a common solvent.
Disinfection connotes the absence of pathogenic life forms. Sterilization connotes the absence of all life forms, whether pathogenic or not. The term decontamination is used herein to connote sterilization, disinfection or other antimicrobial treatments.
Heretofore, medical equipment and instruments have often been decontaminated in a steam autoclave. Autoclaves kill life forms with a combination of high temperature and pressure. However, steam autoclaves have several drawbacks. The high temperature pressure vessels tend to be bulky and heavy. The high temperature and pressure tends to curtail the useful life of endoscopes, rubber and plastic devices, lenses, and portions of devices made of polymeric materials and the like. Moreover, a typical autoclave decontaminating and cool down cycle is sufficiently long that multiple sets of the medical instruments are commonly required.
Instruments which cannot withstand the pressure or temperature of the oven autoclave are often decontaminated with ethylene oxide gas, particularly in larger medical facilities or hospitals. However, the ethylene oxide decontamination technique also has several drawbacks. First, the ethylene oxide decontamination cycle tends to be even longer than the steam autoclave cycle. Another drawback is that ethylene oxide decontamination is sufficiently sophisticated that trained technicians are commonly required, making it unsuitable for physician and dental offices and for other smaller medical facilities. Moreover, some medical equipment can not be decontaminated with ethylene oxide gas.
Liquid decontamination systems have also been utilized for equipment which could not withstand the high temperatures of steam decontamination. Commonly, a technician mixes a liquid disinfectant composition immediately prior to use and manually immerses the items to be decontaminated. The high degree of manual labor introduces numerous uncontrolled and unreported variables into the process. There are quality assurance problems with the weakening of the decontaminant chemicals due to aging on the shelf, and technician errors in the mixing of decontaminant, control of immersion times, rinsing of residue, exposure to the ambient atmosphere after the rinsing step, and the like. On occasion, powdered reagents are carried away from the mixing region and deposited in undesired locations before they dissolve or react. When systems are used for decontaminating medical instruments, undissolved reagent particles remaining on the medical instruments after a decontamination cycle are considered undesirable.
U.S. Pat. No. 5,662,866 to Siegel, et al. discloses a two-compartment cup for powdered sterilant reagent components. An outer cup holds a first reagent while an inner cup, disposed within the outer cup, holds a second reagent. Peripheral walls of inner and outer cups are affixed together at their open ends at flanges. A permeable sheet is affixed to the inner cup portion flange for ventedly sealing both cups. The outer cup is closed at its base by a first detachable base and the inner cup similarly closed by a second detachable base. In use, the two bases are opened to allow mixing of the two reagents. The two-compartment cup ensures sterilization or disinfection with a reproducible, pre-measured dose of reagents, while also facilitating handling and shipping of the reagents.
The present invention provides for a new and improved two compartment package which does not require detachment of first and second compartment bases and which is ideal for storing powdered reagents which are retained separately until time of use and are released in solution when a solvent is passed through both compartments.